Medicinal Products

BILASKA 20 mg

Generic drug of the therapeutic class: Allergology
active ingredients: Bilastine
laboratory: Menarini Inter OP Luxemb

Compressed
Box of 3 blister packs of 10
All forms

Indication

Symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria.

Dosage BILASKA 20 mg Tablet Box of 3 blister packs of 10

Oral way.

Adults and adolescents (over 12 years old)

The recommended dosage is 20 mg (one tablet) once a day.

The tablet should be taken 1 hour before or 2 hours after taking food or fruit juice.

It is recommended to administer the daily dose in a single dose.

Elderly

No dose adjustment is necessary in the elderly (see sections Pharmacodynamic properties and Pharmacokinetic properties ). The experience is limited in people over 65 years old.

Children under 12 years

The effectiveness and safety of bilastine in children under 12 years of age have not been established.

Renal failure

No dose adjustment is necessary in case of renal insufficiency (see section 5.2 Pharmacokinetic properties ).

Hepatic insufficiency

No data are available in patients with hepatic impairment.

Given the absence of metabolism of bilastine and its elimination in majority by urinary route, it is not expected to significantly increase systemic exposure in cases of liver failure beyond safety margins.

Therefore, no dose adjustment is necessary in patients with hepatic impairment (see section 5.2 ).

Duration of treatment

The use of bilastine in the treatment of allergic rhinitis should be limited to the period of exposure to allergens.

In case of seasonal allergic rhinitis, the treatment can be stopped after the disappearance of the symptoms and will be resumed at the time of their reappearance.

In case of perennial allergic rhinitis, continuous treatment could be offered to patients during periods of exposure to allergens.

In cases of urticaria, the duration of treatment will depend on the nature, duration and evolution of the symptomatology.

Against indications

Hypersensitivity to the active substance (bilastine) or to any of the excipients.

Bilaska side effects

In clinical studies, the number of adverse reactions observed in patients with allergic rhino-conjunctivitis or chronic idiopathic urticaria treated with bilastine 20 mg was comparable to that observed with placebo (respectively 12.7% versus 12, 8%).

In the Phase II and III clinical studies, the most common side effects with bilastine 20 mg were: headache, drowsiness, dizziness and fatigue. The frequency of these adverse events was similar in the placebo group.

Adverse events that are at least probably related to bilastine and have a frequency greater than 0.1% are shown in the table below:

The following definitions have been used to classify adverse effects in order of frequency:

Very common (≥ 1/10)

Frequent (≥ 1/100 to <1/10)

Uncommon (≥ 1/1000 to <1/100)

Rare (≥ 1/10 000 to <1/1000)

Very rare (<1 / 10, 000)

Not known (can not be estimated from the available data)

Rare side effects, very rare and those whose frequency is not known, are not reported in the table.

organs

Bilastine 20 mg

N = 1697

Bilastine (all dosages)

N = 2525

Placebo

N = 1362

Frequency

Undesirable effect

Infections and infestations

Rare

Genital herpes

2 (0.12%)

2 (0.08%)

0 (0.0%)

Metabolism and nutrition disorders

Rare

Increased appetite

10 (0.59%)

11 (0.44%)

7 (0.51%)

Psychiatric disorders

Rare

Anxiety

6 (0.35%)

8 (0.32%)

0 (0.0%)

Insomnia

2 (0.12%)

4 (0.16%)

0 (0.0%)

Ear and labyrinth disorders

Rare

tinnitus

2 (0.12%)

2 (0.08%)

0 (0.0%)

Dizziness

3 (0.18%)

3 (0.12%)

0 (0.0%)

Cardiac disorders

Rare

Right branch block

4 (0.24%)

5 (0.20%)

3 (0.22%)

Sinus arrhythmia

5 (0.30%)

5 (0.20%)

1 (0.07%)

QT interval prolongation

9 (0.53%)

10 (0.40%)

5 (0.37%)

Other abnormalities of the ECG

7 (0.41%)

11 (0.44%)

2 (0.15%)

Nervous system disorders

Frequent

Drowsiness

52 (3.06%)

82 (3.25%)

39 (2.86%)

Headache

68 (4.01%)

90 (3.56%)

46 (3.38%)

Rare

Dizzying sensations

14 (0.83%)

23 (0.91%)

8 (0.59%)

Respiratory, thoracic and mediastinal disorders

Rare

Dyspnea

2 (0.12%)

2 (0.08%)

0 (0.0%)

Nasal discomfort

2 (0.12%)

2 (0.08%)

0 (0.0%)

Nasal dryness

3 (0.18%)

6 (0.24%)

4 (0.29%)

Gastrointestinal disorders

Rare

Abdominal pain

11 (0.65%)

14 (0.55%)

6 (0.44%)

Abdominal pain

5 (0.30%)

5 (0.20%)

4 (0.29%)

Nausea

7 (0.41%)

10 (0.40%)

14 (1.03%)

Gastric discomfort

3 (0.18%)

4 (0.16%)

0 (0.0%)

Diarrhea

4 (0.24%)

6 (0.24%)

3 (0.22%)

Oral dryness

2 (0.12%)

6 (0.24%)

5 (0.37%)

Dyspepsia

2 (0.12%)

4 (0.16%)

4 (0.29%)

Gastritis

4 (0.24%)

4 (0.16%)

0 (0.0%)

Skin and subcutaneous tissue disorders

Rare

itching

2 (0.12%)

4 (0.16%)

2 (0.15%)

General disorders and administration site conditions

Rare

Tired

14 (0.83%)

19 (0.75%)

18 (1.32%)

Feeling thirsty

3 (0.18%)

4 (0.16%)

1 (0.07%)

Enhanced pre-existing condition

2 (0.12%)

2 (0.08%)

1 (0.07%)

Fever

2 (0.12%)

3 (0.12%)

1 (0.07%)

Asthenia

3 (0.18%)

4 (0.16%)

5 (0.37%)

investigations

Rare

Increase in gamma GT

7 (0.41%)

8 (0.32%)

2 (0.15%)

Increase in ALT

5 (0.30%)

5 (0.20%)

3 (0.22%)

Increase in ASAT

3 (0.18%)

3 (0.12%)

3 (0.22%)

Increased serum creatinine

2 (0.12%)

2 (0.08%)

0 (0.0%)

Increased triglycerides

2 (0.12%)

2 (0.08%)

3 (0.22%)

Weight gain

8 (0.47%)

12 (0.48%)

2 (0.15%)

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